CARBOPLATIN
CARBOPLATIN- carboplatin injection, USP solution Rx only
Approved
Approval ID
5484d2f0-0cc2-4bba-8f26-c7f6539a9606
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
Manufacturers
FDA
BPI Labs LLC
DUNS: 078627620
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carboplatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54288-167
Application NumberANDA207324
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOPLATINActive
Quantity: 10 mg in 1 mL
Code: BG3F62OND5
Classification: ACTIB
Carboplatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54288-166
Application NumberANDA207324
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOPLATINActive
Quantity: 10 mg in 1 mL
Code: BG3F62OND5
Classification: ACTIB
Carboplatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54288-164
Application NumberANDA207324
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (2)
CARBOPLATINActive
Quantity: 10 mg in 1 mL
Code: BG3F62OND5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Carboplatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54288-165
Application NumberANDA207324
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carboplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOPLATINActive
Quantity: 10 mg in 1 mL
Code: BG3F62OND5
Classification: ACTIB